Negative pressure wound therapy for surgical wounds healing by primary closure.
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ABSTRACT:
SUBMITTER: Norman G
PROVIDER: S-EPMC7389520 | biostudies-literature |
REPOSITORIES: biostudies-literature
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| S-EPMC6434581 | biostudies-literature
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| S-EPMC7192856 | biostudies-literature
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| S-EPMC9040710 | biostudies-literature
Project description:BackgroundSurgical wounds healing by secondary intention (SWHSI) are increasingly being treated with negative-pressure wound therapy (NPWT) despite a lack of high-quality research evidence regarding its clinical and cost-effectiveness. This pilot feasibility RCT aimed to assess the methods for and feasibility of conducting a future definitive RCT of NPWT for the treatment of SWHSI.MethodsEligible consenting adult patients receiving care at the study sites (2 acute and 1 community) and with a SWHSI appropriate for NPWT or wound dressing treatment were randomized 1 : 1 centrally to receive NPWT or usual care (no NPWT). Participants were followed up every 1-2 weeks for 3 months. Feasibility (recruitment rate, time to intervention delivery) and clinical (time to wound healing) outcomes were assessed.ResultsA total of 248 participants were screened for eligibility; 40 (16·1 per cent) were randomized, 19 to NPWT and 21 to usual care. Twenty-four of the 40 wounds were located on the foot. Participants received NPWT for a median of 18 (range 0-72) days. Two participants in the NPWT group never received the intervention and 14 received NPWT within 48 h of randomization. Five participants in the usual care group received NPWT during the study. Ten of the 40 wounds were deemed to have healed during the study.ConclusionA full-scale RCT to investigate the clinical and cost-effectiveness of NPWT for SWHSI is feasible. This study identified crucial information on recruitment rates and data collection methods to consider during the design of a definitive RCT. Registration number: ISRCTN12761776 (http://www.iscrtn.com).
| S-EPMC5989956 | biostudies-literature
Project description:Following excision of musculoskeletal tumours, patients are at high risk of wound issues such as infection, dehiscence and delayed healing. This is due to a multitude of factors including the invasive nature of the disease, extensive soft tissue dissection, disruption to blood and lymphatic drainage, residual cavity and adjuvant therapies. The use of negative pressure wound therapy (NPWT) has a growing body of evidence on its beneficial effect of wound healing such as promoting cell differentiation, minimising oedema and thermoregulation. Traditionally, these dressings have been used for open or dehisced wounds; however recent research has investigated its role in closed wounds.AimTo evaluate the effect of NPWT in patients with closed wounds, either primarily or with flap coverage, in our high risk group. Consecutive patients who had a NPWT dressing applied were selected, and a control group was established by a blinded researcher with matching for tissue diagnosis, surgical site, gender and age. The primary outcome measured was documented for wound complications, with secondary data collected on radiotherapy and wound drainage.ResultsPatients were well matched between the intervention (n=9) and control (n=9) groups for gender, age and tissue diagnosis. Both groups had 1 patient who underwent preoperative radiotherapy. A total of 3 wound infections occurred in the control group and none in the NPWT group. Overall there was a trend towards lower drain output and statistically significantly reduced infection rate in the NPWT group.ConclusionIn this short series, despite the NPWT patients having more additional risk factors for wound issues, they resulted in fewer infections. The sample size is not sufficient to have statistically significant reduction. Further evaluation on the value of NPWT in this patient group should be prospectively evaluated.
| S-EPMC5481620 | biostudies-literature
Project description:Most incisions following surgery heal by primary intention, with the edges of the wound apposed with sutures or clips. However, some wounds may break open or be left to heal from the bottom up (i.e. healing by secondary intention). Surgical Wounds Healing by Secondary Intention (SWHSI) are often more complex to manage, and require additional treatments during the course of healing. There is significant uncertainty regarding the best treatment for these complex wounds, with limited robust evidence regarding the clinical and cost-effectiveness of different dressings and treatments; one such treatment is Negative Pressure Wound Therapy (NPWT) which is frequently used in the management of SWHSI. Previous randomised controlled trials (RCTs) of NPWT have failed to recruit to time and target, thus we aimed to conduct a pilot RCT to assess the feasibility of conducting a future, full-scale RCT.This pilot RCT will test the methods and feasibility of recruiting, randomising, and retaining participants into a larger trial of NPWT verses usual care for patients with SWHSI. Participants will be randomised to receive either NPWT or usual care (no NPWT) and will be followed up for 3 months.This study will provide a full assessment of methods for, and feasibility of, recruiting, randomising, and retaining patients with SWHSI in a trial of NPWT versus usual care. On the basis of this pilot trial, a full trial may be proposed in the future which will provide additional, robust evidence on the clinical and cost-effectiveness of NPWT in the management of SWHSI.Clinical Trial Registry: ISRCTN12761776 , registered on 10 December 2015 - retrospective registration.
| S-EPMC5100221 | biostudies-other
Project description:BackgroundThe majority of surgical wounds are closed (for example with sutures or staples) and so heal by primary intention. Where closure is not possible, or the wound subsequently breaks down, wounds may be left to heal from the bottom up (healing by secondary intention). Surgical wound healing by secondary intention (SWHSI) frequently presents a significant management challenge. Additional treatments are often required during the course of healing, and thus a significant financial burden is associated with treating these wounds. Increasingly, negative pressure wound therapy (NPWT) is used in the management of SWHSI. This wound dressing system provides a negative pressure (vacuum) to the wound, removing fluid into a canister, which is believed to be conducive to wound healing. Despite the increasing use of NPWT, there is limited robust evidence for the effectiveness of this device. A well-designed and conducted randomised controlled trial is now required to ascertain if NPWT is a clinically and cost-effective treatment for SWHSI.MethodsSWHSI-2 is a pragmatic, multi-centre, cross surgical specialty, two arm, parallel group, randomised controlled superiority trial. Adult patients with a SWHSI will be randomised to receive either NPWT or usual care (no NPWT) and will be followed up for 12 months. The primary outcome will be time to healing (defined as full epithelial cover in absence of a scab) in number of days since randomisation. Secondary outcomes will include key clinical events (hospital admission or discharge, treatment status, reoperation, amputation, antibiotic use and death), wound infection, wound pain, health-related quality of life, health utility and resource use.DiscussionGiven the increasing use of NPWT, despite limited high-quality supporting evidence, the SWHSI-2 Trial will provide robust evidence on the clinical and cost-effectiveness of NPWT in the management of SWHSI. The SWHSI-2 Trial opened to recruitment in May 2019 and is currently recruiting across 20 participating centres.Trial registrationISRCTN 26277546 . Prospectively registered on 25 March 2019.
| S-EPMC8543414 | biostudies-literature
Project description:Case:A 53-year-old woman developed septic shock associated with non-clostridial gas gangrene. She presented to the emergency department with two large open wounds on both thighs and in her sacral region. Non-enhanced computed tomography showed air density in contact with the right iliopsoas, which extended to the posterior compartment of the thigh. We made repeated efforts at surgical debridement of the wound with resection of necrotic tissues. Outcome:Using negative pressure wound therapy-assisted dermatotraction, the pus pockets and the wound dehiscence decreased in size. Using this method we were successful in achieving delayed closure without skin grafts. Conclusion:Negative pressure wound therapy can be an effective treatment for large and infected open contoured wounds. Negative pressure wound therapy-assisted dermatotraction might be beneficial for poorly healing, large, open wounds in patients in poor condition and with insufficient reserve to tolerate reconstructive surgery.
| S-EPMC5667385 | biostudies-literature
Project description:BackgroundSurgical site infections (SSI) in the groin after vascular surgery are common. The aim of the study was to evaluate the effect of negative pressure wound therapy (NPWT) on SSI incidence when applied on closed inguinal incisions after endovascular aneurysm repair (EVAR).MethodsA multicenter randomized controlled trial (RCT). Between November 2013 and December 2020, 377 incisions (336 bilateral and 41 unilateral) from elective EVAR procedures with the primary intent of fascia closure were randomized and included, receiving either NPWT or a standard dressing. In bilateral incisions, each incision randomly received the opposite dressing of the other side, thereby becoming each other's control. The primary endpoint was SSI incidence at 90 days postoperatively, analyzed on an intention-to-treat basis. Uni and bilaterally operated incisions were analyzed separately, and their respective p-values combined using Fisher's method for combining P-values. Study protocol (NCT01913132).ResultsThe SSI incidence at 90 days postoperatively in bilateral incisions was 1.8% (n = 3/168) in the NPWT and 4.8% (n = 8/168) in the standard dressing group, and in unilateral incisions 13.3% (n = 2/15) and 11.5% (n = 3/26), respectively (combined p = 0.49). In all SSIs, bacteria were isolated from incisional wound cultures. No additional SSIs were diagnosed between 90 days and 1 year follow-up.ConclusionsNo evidence of difference in SSI incidence was seen in these low-risk inguinal incisions when comparing NPWT with standard dressings after EVAR with the primary intent of fascia closure.Clinical trialsNCT01913132.
| S-EPMC9636293 | biostudies-literature
Project description:Background:It has been proposed that negative pressure wound therapy (NPWT) applied prophylactically to a closed incision may decrease the incidence of wound complications. Patients undergoing reduction mammaplasty are at risk of wound complications such as delayed healing, infection, and dehiscence, and the bilateral nature of the surgery allows for a within-patient randomized study to evaluate incisional NPWT's effect in reducing healing complications. Methods:In this multicenter trial, 200 patients undergoing bilateral reduction mammaplasty were treated with PICO Single-Use NPWT System or standard wound-care dressings randomized to right or left breast for up to 14 days to enable within-patient comparison. Follow-up assessments were conducted to evaluate the difference in incision healing complications up to 21 days postsurgery. Healing complications (for the primary endpoint) were defined as delayed healing (incision not 100% closed by 7 days) and occurrence of dehiscence or infection within 21 days. Individual healing complications were assessed separately as secondary endpoints. Results:Significantly fewer healing complications (primary endpoint) were noted in NPWT-treated breasts [113 (56.8%)] versus standard care [123 (61.8%)]. The difference of 10 (5.0%) patients with fewer healing complications using NPWT was statistically significant (P = 0.004). NPWT also resulted in a significantly lower incidence of dehiscence (secondary endpoint) compared with standard care [32 patients (16.2%) versus 52 patients (26.4%)] by day 21, a relative reduction of 38% (P < 0.001). Conclusions:This is the first major prospective, within-patient, randomized, controlled, multicenter study to provide evidence for an incisional NPWT strategy to reduce healing complications.
| S-EPMC5811280 | biostudies-literature